inReach^TM System

An Unmet Clinical Need

As the incidence of lung disease grows in the United States, the challenge of early and accurate diagnosis and treatment of lung lesions is becoming more critical. There is an urgent need for a reliable, minimally invasive tool for accessing lung lesions, especially those located beyond the reach of traditional bronchoscopes.

Peripheral lung lesions are beyond the reach of conventional bronchoscopes.

Although 1 in 500 chest x-rays show a peripheral lesion¹, 65% of traditional bronchoscopes fail to reach these distant lesions². More invasive diagnostic techniques are then necessary, posing a greater potential for complications such as pneumothorax³. Patients with poor lung function may not tolerate more invasive procedures, leaving them with "watchful waiting" as their only option.

Yet, early diagnosis and treatment are crucial for improving survival rates in malignant lung disease. A recent study determined that lung lesions diagnosed early (Stage I) resulted in a survival rate of 88% at 10 years⁴. Compare this to lung cancer patients diagnosed at Stage III or IV where survival rates typically are 15% at 5 years⁵.

The superDimension inReach System addresses this unmet medical need by enabling physicians to access peripheral lung lesions and mediastinal lymph nodes with a minimally invasive technique suitable even for patients who cannot undergo more invasive procedures. With the inReach System, physicians gain access to distal lesions in a minimally invasive manner.

inReach Electromagnetic Navigation Bronchoscopy System

inReach System Components

The inReach System consists of:

• A disposable guide catheter that extends beyond the reach of the bronchoscope and becomes an extended channel for endobronchial tools to distal locations in the lungs and mediastinum
• A disposable steerable navigation catheter that contains a location sensor at its distal tip and allows 360 degree steerability through the bronchial tree
• Planning and navigation software, providing physicians with a reconstruction of the bronchial airways of the lungs.
• Hardware, including a localization system, computer and monitor, providing physicians with a real-time position of the catheters within the lungs

The inReach navigation catheter has 360 degree steerability within the lungs.

inReach Process

Using Global Positioning System (GPS) like technology, the inReach System provides a three-dimensional virtual "roadmap" of the lungs that enables a physician to maneuver the inReach catheters through multiple branches of the bronchial tree to reach targeted lesions.

After the patient's previously acquired CT scan of the lungs is imported into the inReach planning laptop, three distinct phases comprise the inReach process:

Planning Phase

• The inReach planning software generates a three-dimensional image of the patient's lungs.
• The physician marks the patient's anatomical points and targets lesions on the virtual and CT images.
• The physician uses the virtual and CT images to plan the path that the inReach catheters will follow in the bronchial tree.
• The patient's virtual plan is saved and exported to a flash drive.

Registration Phase

• The patient's virtual plan is downloaded into the inReach System computer.
• A conventional bronchoscope is inserted.
• The inReach catheters are inserted into the bronchoscope channel.
• The physician uses the location sensor at the navigation catheter's tip to mark the actual anatomy of the patient in the positions marked earlier on the virtual and CT images. This provides a "registration" of the pre-acquired CT scan to the patient's anatomy.

Navigation Phase

• The physician uses the CT images and steering directions on the inReach monitor to navigate the inReach catheters to target areas in real time.
• The guide catheter is locked in place and the steerable navigation catheter is removed.
• Endobronchial tools are inserted through the guide catheter and used to collect tissue samples.

Versatile Solutions

The inReach System has demonstrated versatility and safety in reaching peripheral locations in the lungs for diagnosing and staging lung disease.^6,7,8

The inReach System technology offers a solution for navigating and imaging that:

• Provides access to peripheral lung lesions when they are small and potentially easier to treat
• Is minimally invasive, usable in a wide variety of patients, including those in whom more invasive techniques are not suitable
• Allows staging of mediastinal lymph nodes
• Enables a physician to preview and plan navigation through the bronchial tree before the procedure begins
• Presents a low risk for pneumothorax (2.3%, comparable to standard bronchoscopy)⁷

Bronchoscopy
The inReach System extends the reach of a conventional bronchoscope for earlier diagnosis and faster staging of lung disease located in distal regions. With inReach, a conclusive diagnostic rate of 69-74% in peripheral lesions^6,9 and 94-100% in lymph nodes has been achieved.^6,10

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Dye Marker Placement

The inReach System now enables pulmonologists to place dye markers in peripheral lung lesions and near the pleura surface providing thoracic surgeons with accurate guidance during Video-Assisted Thoracoscopic Surgery (VATS).  Using Electromagnetic Navigation Bronchoscopy, the inReach System provides a means for visual identification of lung nodules that may not be visible at the time of surgery for ‘true’ excisional biopsy.  Successful identification of the nodule may enable surgeons to preserve the VATS approach.  Dye marker placement provides a potential for better outcomes, including reduced complications and getting a definitive diagnosis and/or treatment solutions in a less invasive manner.

The following links below will provide you with additional information on Dye Marker Placement for VATS using the inReach System.

• Dye Marker Summary Sheet
• Dye Marker Placement Using the inReach System – A White Paper
• Dye Marker Placement Brochure

Radiosurgical Marker Placement

Using the inReach System, pulmonologists can now transbronchially place radiosurgical markers in and around lung tumors to help radiation oncologists better plan and treat patients with external beam radiation. The inReach System uses Electromagnetic Navigation Bronchoscopy to place radiosurgical markers enabling physicians to carefully track changes in tumor position during radiation therapy and tumor morphology over time.  Radiosurgical marker placement provides the potential for better outcomes including reduced complications and getting a treatment solution in a less invasive manner. 

The following links below will provide you with additional information on Radiosurgical Marker Placement for IGRT using the inReach System.

• Radiosurgical Marker Summary Sheet
• Radiosurgical Marker Placement Using the inReach System – A White Paper
• Radiosurgical Marker Placement Brochure

Technical Support

For technical support, please call superDimension Customer Service at 1-800-387-9016.

References

1. Tan BB, Flaherty KR, Kazerooni EA, et al. The solitary pulmonary nodule. Chest 2003; 123 (Suppl):89S-96S.
2. Schwarz Y, Greif J, Becker HD, et al. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images – the first human study. Chest 2006; 129:988-994.
3. Cox J, Chiles C, McManus C, et al. Transthoracic needle aspiration biopsy: variables that affect risk of pneumothorax. Radiology 1999; 212:165-68.
4. International Early Lung Cancer Action Program Investigators. Survival of patients with Stage I lung cancer detected on CT screening. The New England Journal of Medicine 2006; 355:1763-71.
5. Ries L, Eisner M, Kosary C, et al. SEER Cancer Statistics Review, 1975-2003, National Cancer Institute, Bethesda MD, http://seer.cancer.gov/csr/1975_2003/.
6. Gildea TR, Mazzone PJ, Kamak D, et al. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. American Journal of Respiratory and Critical Care Medicine 2006; 174:982-89.
7. Eberhardt R, Anantham D, Herth F, et al. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest 2007; 131:1800-05.
8. Markris D, Scherpereel A, Leroy S, et al. Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. European Respiratory Journal 2007: 29:1187-92.
9. Becker HD, Herth F, Ernst A, et al. Bronchoscopic biopsy of peripheral lung lesions under electromagnetic guidance; a pilot study. Journal of Bronchoscopy 2005; 12:9-13.
10. Wilson DS, Bartlett RJ. Improved diagnostic yield of bronchoscopy in a community practice: combination of electromagnetic navigation system and rapid on-site evaluation. Journal of Bronchology 2007; 14:227-232.